CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 110 enrolled
Drug / intervention
Ondansetron +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03239210
NCT03239210Phase 4Completed

Effects of Ondansetron in Obsessive-compulsive and Tic Disorders

NYU Langone Health·interventional·Posted Aug 3, 2017·Updated May 3, 2024

In Brief

A Phase 4 clinical trial evaluating Ondansetron and Placebo for Obsessive-Compulsive Disorder and 2 related conditions. Completed, enrolled 110 participants across 2 sites.

Detailed Summary

This project investigates the use of 4 weeks of 24 mg/day ondansetron as compared to placebo on symptoms and brain functioning in patients with obsessive-compulsive disorder (OCD) and tic disorders (TD). Patients will be randomized to receive ondansetron or placebo for 4 weeks, with MRI scans and symptom assessments occurring at baseline (before any drug) and at the end of the 4 weeks. Patients will also be asked to come into the lab approximately 2 weeks into the trial for symptom assessments. The investigators hypothesize that after 4 weeks there will be greater reduction from baseline in sensory symptoms and the activation of the insula and sensorimotor cortex compared for ondansetron as compared to placebo.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Phase 4CompletedFinished
201820192020202120222023202420252026
First PostedAug 3, 2017
Enrollment StartJun 16, 2017
Primary CompletionMay 16, 2022
TodayJul 2, 2026
Enrollment to primary: 4.9 yearsPosted 8.9 years ago

Interventions

Ondansetrondrug

5-HT3 (serotonin receptor type 3) antagonist commonly used to treat nausea and vomiting

Placebodrug

placebo equivalent